Principal Quality Assurance Engineer

7 days ago

Dublin, Dublin City, Ireland beBeeQuality Full time €45,000 - €65,000

About the Role:

This is a high-profile position that involves leading the implementation of our quality management system, with a focus on continuous improvement.

The successful candidate will be responsible for supporting manufacturing, supply chain, and design assurance activities across various functions within the organization. This includes ensuring compliance with regulatory standards and representing the quality function in cross-functional collaborations.

Key Responsibilities:

  • Leverage expertise to drive day-to-day quality management system implementation
  • Facilitate QMS continuous improvement initiatives
  • Elevate overall quality strategy and contribute to business quality objectives
  • Cultivate collaboration with wider teams to ensure QA activities are planned, executed, and documented
  • Interpret relevant standards to guarantee company meets requirements
  • Develop and review test specifications, part specifications, and design specifications in conjunction with cross-functional teams
  • Sustain manufacturing team activities related to regulated environments
  • Provide practical QA and Design Assurance expertise
  • Support supply chain activities associated with suppliers, including process development and manufacturing requirements
  • Coordinate and manage key activities such as internal audits, material reviews, CAPA reviews, complaint processes, project support for regulatory submissions, and clinical investigations

Requirements:

  • Bachelor's Degree in Engineering, Science, or related field
  • At least 3 years' experience in medical device quality/design assurance roles
  • Recent regulatory experience encompassing FDA regulations, ISO 13485, Medical Device Directive, and other applicable national and international regulations and standards

Desirable Skills:

  • Master's degree in Engineering, Science, or related field
  • Experience in implantable medical devices
  • Expertise in process development and change management within regulated environments

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